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"Only 35 percent of patients with lipid problems are currently beingtreated with lipid therapies and many are not reaching treatment targets forall three key lipids," said Michael Davidson, M.D., clinical professor anddirector of Preventive Cardiology, University of Chicago Pritzker School ofMedicine. "The approval of TRILIPIX is good news for patients because nowthere is a new treatment option that can be used alone or in combination witha statin to help address lipid problems."
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TRILIPIX was studied in 2,698 patients with mixed dyslipidemia, a disorderof all three key lipids affecting millions of American adults. In theTRILIPIX studies, mixed dyslipidemia was characterized by elevated LDL (badcholesterol) and triglycerides (a type of fat found in the blood) and low HDL(good cholesterol). These studies demonstrated that TRILIPIX used incombination with the most commonly prescribed statins helped patients manageall three key lipids better than the corresponding therapies alone.
Treatment guidelines endorsed by the National Cholesterol EducationProgram (NCEP), the American College of Cardiology and the American HeartAssociation have called for more aggressive management of lipids, including alower LDL goal for many patients, as well as more aggressive management of HDLand triglycerides.
About the TRILIPIX Clinical Trial Program
The FDA's approval of TRILIPIX was based on the largest clinical trialprogram to date designed to evaluate the efficacy and safety of a fibrate incombination with various statins. The efficacy and safety of TRILIPIX incombination with the three most commonly prescribed statins -- rosuvastatin,atorvastatin and simvastatin -- was evaluated in three randomized,multicenter, double-blind, controlled, 12-week Phase III studies, totaling2,698 patients with mixed dyslipidemia. Patients included in the studies hadmultiple lipid problems, with an LDL > 130 mg/dL, triglycerides > 150 mg/dLand HDL less than 40 mg/dL for men and less than 50 mg/dL for women. A totalof 1,911 patients who completed one of the 12-week studies subsequentlyenrolled in a 52-week long-term, open-label extension study.
The Phase III combination studies all met their primary endpoints.Combination therapy significantly improved HDL and triglycerides compared tostatin therapy alone, and significantly improved LDL compared to TRILIPIXalone. All of the combinations and the statins had clinically meaningfulreductions in LDL.
"Physicians told us that they needed data supporting the use of a fibratewith statins to help them more aggressively manage their patients' lipidproblems," said Eugene Sun, M.D., vice president, Global PharmaceuticalClinical Development, Abbott. "Abbott built a robust clinical program tosupport the use of TRILIPIX, and its approval adds a new option to Abbott'sgrowing dyslipidemia portfolio which provides treatments to comprehensivelyhelp address all three key lipids."
Abbott and AstraZeneca are working together to develop a fixed-dosecombination of Abbott's TRILIPIX and AstraZeneca's CRESTOR(R) (rosuvastatincalcium) with plans to submit a new drug application to the FDA in 2009. Thecompanies also recently announced an agreement under which Abbott's salesforce will co-promote CRESTOR in the United States.
TRILIPIX Indications
TRILIPIX is a prescription medicine used along with diet in adults tolower triglycerides and LDL (bad) cholesterol, and increase HDL (good)cholesterol. TRILIPIX can be used alone or with another cholesterol-loweringmedicine called a statin. TRILIPIX has not been shown to prevent heartdisease or heart attack.
Important Safety Information About TRILIPIX
TRILIPIX should not be taken by people with liver, gallbladder, or severekidney disease, nursing mothers, or those allergic to any product ingredient.Unexplained muscle pain, tenderness, or weakness may be a sign of a seriousside effect and should be reported to a healthcare provider right away.Rarely, muscle-related problems can cause kidney damage. These side effectsmay be increased when TRILIPIX is used with a statin. Patients should telltheir healthcare provider about all the medicines they take to help avoidserious side effects. Blood tests may be performed before and duringtreatment with TRILIPIX. Patients should contact their healthcare provider ifthey experience abdominal pain, nausea or vomiting while taking TRILIPIX.These may be signs of inflammation of the gallbladder or pancreas. Women whoare pregnant should not take statins and should talk with their healthcareprovider about TRILIPIX if they are pregnant or may become pregnant. The mostcommon side effects with TRILIPIX include headache, heartburn, nausea, muscleaches and increases in muscle or liver enzymes that are measured by bloodtests. Full Prescribing Information is available athttp://www.rxabbott.com/pdf/trilipix_pi.pdf. Visit http://www.trilipix.com orcall Abbott Medical Information at 1-800-633-9110 for more information aboutTRILIPIX.
About Abbott
Abbott (NYSE: ABT) is a global, broad-based health care company devoted tothe discovery, development, manufacture and marketing of pharmaceuticals andmedical products, including nutritionals, devices and diagnostics. Thecompany employs more than 68,000 people and markets its products in more than130 countries.
Abbott's news releases and other information are available on the company'sWeb site at http://www.abbott.com.To view the Multimedia News Release, go to:http://www.prnewswire.com/mnr/abbott/35271/
SOURCE Abbott
